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June 2014 - Newsletter

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Parallel Sessions at NYSORA

In this issue:

NYSORA September Symposium

Research Tips by Dr Maxine Kuroda


Dr Maxine Kuroda

Clinical Research is essential for advancement of medicine. However, the benefit of any research activity is directly related to the quality of research, data obtained, and proper treatment of the data. Perhaps one of the most important steps in conducting clinical research is advanced planning with a statistician or epidemiologist. In this issue of the NYSORA newsletter, Dr Maxine Kuroda, PHD shares a few crucial steps in designing and conducting clinical research.

1. Planning
        a. General concepts
                i. What questions are driving the research?
                ii. What are the clinical implications of the research?
                iii. Will the research contribute new information? (Even if the intention is to expand on previous findings
                     - in what way is such 'expansion' likely to contribute to the field?)
        b. Focus
                i. Goals
                      1. To share a case report
                      2. To describe the experiences of a case series
                      3. To conduct a clinical trial
                      4. Note: There is nothing wrong with observational research. In fact, this is often the only type of
                          research that is feasible. Moreover, clinical trials are not generalizable beyond the
                          imposed parameters of the study and its research subjects.
                ii. Specific aims
                      1. Typically, new investigators want to answer all the questions and solve all of the problems in their
                          field.
                      2. However, most studies should be limited to 1 or 2 very specific aims.
                      3. Note: Once data collection has begun, these aims cannot be changed. This is because study
                          measures were pre-selected for their usefulness in addressing the specific aims. The same
                          measures may not be able to address specific aims that have been changed - or there may be
                          other measures that are better suited to answering specific aims that have been changed.
                iii. Hypotheses to be tested
                      1. These are research ('alternative') hypotheses that are presented as simple declarative sentences.
                          Null hypotheses of no effect or no difference are not stated. This is not a silly point - for instance,
                          often times investigators want to look at whether a new procedure or drug has the same success
                          rate as an established procedure or drug. (Why would a new modality want to be statistically
                          similar to that of the established modality?)
                      2. To a statistician, this is one of the most important elements overall. It is extremely helpful when
                          investigators come prepared with written statements that can serve as a springboard for
                          discussion. Indeed, it should be a requirement that investigators come prepared with written
                          pecific aims and/or hypotheses.
                      3. Note: Once data collection has begun, hypotheses cannot be changed. This is because the Type I
                          error can be elevated when data have been previewed (even inadvertently).
        c. Facility resources
                i. Institutional support
                ii. Equipment/instruments
                iii. Personnel - Various levels and experience may be needed for the study. Clinical staff may need special
                    training. Research assistants will need to learn, understand, and practice the study protocol.
                iv. IRB submissions - Since IRB requirements vary widely by institution, these submissions would need to
                    be the responsibility of the investigator and his/her research assistants. However, statistical input
                    is required as most IRBs require sample size estimates and a brief statistical analysis plan (SAP).
        d. Data
                i. What data are needed to answer the research questions?
                ii. Have instruments or questionnaires been developed that collect the information needed for the study?
                    For questionnaires - Have their reliability and validity been established? For instruments - How precise
                    are they and what are their standard errors of precision?
                iii. What are the data metrics? This ensures that data are submitted to the appropriate statistical
                    approaches when testing hypotheses, and that findings are properly tabled and/or graphed.
                iv. Are research subjects, volunteers, cadavers, or surveys to be used? What are the inclusion and
                    exclusion criteria? Rationale for same?
                v. What are the advantages of the chosen study design, methods, and measures? What are its
                    limitations? It is useful to record why it was deemed possible to proceed with the study in view of
                    any limitations identified in the planning phase of the study.
                vi. Sample size cannot be estimated without information obtained from this planning phase of the
                    research. Besides the usual parameters (study design, Type I error rate, power, size of effect),
                    estimated loss to follow-up and multiple comparisons are useful to consider. Sample size parameters
                    often come from the literature and/or pilot studies.
        e. Additional notes
                i. The planning phase is the most critical (make-or-break) phase of research. It is not too early to start
                   drafting the Introduction and Materials and Methods sections. It even makes sense to discuss journals
                   that might be interested in publishing the research.
                ii. It is possible to prepare via emails among the investigators, however, much depends on how
                    like-minded and committed the investigators are. Besides potential for confusion, elements of research
                    will be weakened without consensus among investigators in the planning phase. For instance, will
                    methodology/equipment need to be modified? If so, are these acceptable to everyone?
2. Monitoring
        a. Recruitment of subjects/volunteers should be tracked.
        b. Returned surveys and follow-up phone calls should be tracked.
        c. IRB approvals are typically renewed once a year and require a progress report.
        d. Data quality
                i. Holes in the data - If data are missing, why? Was there insufficient training of research assistants? Was
                   there a change of research assistants? Was there miscommunication between nursing staff and
                   research assistants? Were eligible subjects missed?
                ii. If blinded, is the 'blind' in tact? Even 'close call' breaches should be identified in order to prevent future
                    occurrences.
                iii. Outliers - Research assistants should investigate and correct (if typographical errors)
                    any values that seem to be aberrant (e.g., male on one form and female on another, age 45 on one form
                    and 54 on another, negative instrument/equipment values when only positive values are physiologically
                    possible). This will save time when resolving outlying values later identified by the statistical analyst.
        e. Interim checks should be stated a priori. Unless already stated in the research and statistical plan, it is not
            really kosher to conduct an interim analysis based on trends have been observed in the data. This is
            because luck-of-the-draw could suggest a result that may differ from that which would actually obtain
            if the entire sample was studied. Since the sample size was calculated to answer a specific question, why
            would an investigator use just part of it? (For clinical trials of, say, a new drug, interim analyses would have
            been incorporated in the research plan for patient safety.)
        f. Protocol violations should be recorded. This will come in handy when writing the paper.
        g. Ideas for the Discussion section (including advantages and limitations of the study) that occur to the
            investigators and research associates should be recorded as the study progresses.
3. Analyzing results
        a. Data analyses should follow the SAP and should be kept as simple and straightforward as possible. This is
            because fancy statistics are usually not warranted, and even informed readers tend not to understand them.
            The danger is that the readers will rely on the statistical reviewer's judgment and simply accept the
            analyses at face value. Unfortunately, research that is not fully understood does not fully contribute to the
            field.
        b. Tables are constructed.
        c. Non-clinical figures are graphed. Note that these figures depend on the data metric, e.g., scatterplots are
            used when both variables are continuous.
        d. Results are written in a very straightforward manner that does not regurgitate the tables or figures.
        e. Results should directly address the hypotheses that were stated at the outset.
4. Editing
        a. A manuscript should flow so that the readers can follow without getting whiplash. But even with good flow,
            paragraphs can get confusing if the writer adds information that is tangential and/or distracting.
        b. Direct, active sentences are preferred.
        c. Study findings should not be overstated or grandiose. For instance, 'superior anesthesia' should not be
            claimed unless the study tested all of the factors that go into 'superiority.' A study may have tested time to
            anesthesia onset, occurrence of adverse effects, and patient satisfaction, but may not have tested ease of
            administration, need for expensive equipment or additional personnel, and cost.

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NYSORA Around the World


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NYSORA Latin America Personal Perspective


Dr Espinoza instructing on US

I work at the Clinical Hospital of the University of Chile, the teaching hospital with the most experience and expertise in the training of Anesthesiologists in my country. Formal teaching in regional anesthesia was incorporated into the curriculum in 2004 through an ongoing theoretical course in which the foundations of regional anesthesia are delivered to residents before they perform clinical rotation. This includes relevant anatomy through lectures and workshops using cadavers, specific kinds of blocks, the bases of ultrasound-guided neurolocalization and neurostimulation, a class on complications, and practice on phantoms. Prior to 2004, residents were only subject to clinical rotation with no theoretical bases being delivered to them. During clinical rotation, residents not only perform blocks/blocking, but also have to undertake strict blocking control on each patient; this allows more rigorous and improved pain control and feedback. While ultrasound has enabled more widespread adoption of regional anesthesia, the focus of our teaching is not only placed on the procedure itself, but on the bases that allow adequate global practice.

Ultrasound Training on a Meat Model

In our country there is concern about maintaining a good standard in the practice of regional anesthesia, and the Chilean Society of Anesthesiology has a committee (CARSACH : Regional Anesthesia Committee of the Chilean Society of Anesthesia) which continuously conducts activities and courses for anesthesiologists and anesthesiology residents from different training programs.

Dr Espinoza in the OR

The 1st Latin American NYSORA, held in Florianopolis this year, has undoubtedly been a great contribution since it provides South American countries access to a top-level program and guests. In addition, the availability of workshops with experienced tutors provides opportunities for conversation, discussion and exchange of experiences. In the same vein, it is important to incorporate scholarships for residents, who can participate more actively in the course while receiving the benefits of assisting to courses at this level. The above results in an improvement of the standard of the practice of regional anesthesia in the region and in the training of future anesthesiologists who may practice regional anesthesia with a critical and rational spirit.

We hope to have NYSORA in Chile one day!!!

Dr. Ana Maria Espinoza
Associate Professor
Dept. of Anesthesiology
University of Chile

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Featured Educational Video - Ultrasound-Guided Axillary Brachial Plexus Block


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NYSORA Symposiums and Workshops


 

 NYSORA Education Program

 Location

 Date

 Registration

 1

 NYSORA Boutique Workshop

 New York City, NY

 March 29-30, 2014

 Sold-Out

 2

 NYSORA Boutique Workshop

 New York City, NY

 May 17-18, 2014

 Closed

 3

 NYSORA Boutique Workshop

 New York City, NY

 June 28-29, 2014

 Closed

 4

 NYSORA Boutique Workshop

 New York City, NY

 July 26-27, 2014

 Closed

 5

 NYSORA Symposium

 New York City, NY

 September 20-21, 2014

 Open

 6

 NYSORA Boutique Workshop

 New York City, NY

 October 25-26, 2014

 Open

 7

 NYSORA Boutique Workshop

 New York City, NY

 December 6-7, 2014

 Open

 8

 NYSORA Inspire Seminar

 Mont-Tremblant, Quebec

 Jan 29 - Feb 01, 2015

 Open

 9

 NYSORA Latin America

 Cartagena, Colombia

 April 9 - 12, 2015

 Open

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